The present invention relates to a system and a method for transferring and moving elements of an automatic packaging machine.
In particular, the invention relates to a system and a method for performing a plurality of operations automatically or semiautomatically on elements, parts and components of a machine for packaging products, for example drugs, placed inside an aseptic and/or sterile environment, to which the following description will make explicit reference without thereby losing general applicability.
In the pharmaceutical and biotechnological industries there is often a requirement for product packaging processes to use sterile materials and in sterile environments in order to prevent the products suffering particle and bacteriological contamination, i.e. contamination due to the presence in the air of solid suspended particles such as ashes, dust, spores and microorganisms.
For this purpose, the production systems comprise packaging machines or lines inserted inside cleanrooms, which separate an internal processing environment, in fact a sterile processing environment, from a surrounding non-sterile external environment, or environment having a different class of sterility or contamination. The degree of contamination of an environment is defined by the number of polluting particles present in a unit volume of air. Standard tables define contamination classes for each of which there is defined the maximum permissible number of polluting particles of the indicated dimension per cubic foot (US FED STD 209 Cleanroom standards) or per cubic metre of air (ISO 14644-1 Cleanroom standards).
The contamination class required in the process environment is a function of the product to be packaged. For example, for pharmaceutical products to be administered parenterally or nasally, or ophthalmic products, packaging in a class ISO 5 (ISO 14644-1) or class 100 (US FED STD 209) environment is required.
The separation and insulation between the two environments in some applications also aims to prevent the dispersal into the external environment of products that are potentially toxic and harmful to human health.
The asepsis and/or sterility of the processing environment is ensured by the cleanliness and sterility of each component and element contained inside the cleanroom, and by the presence of a suitable one-way flow of sterile air filtered by suitable absolute (HEPA) filters. The one-way air flow consists of threads of sterile air that move in the same direction almost parallel to one another, at substantially the same speed, in such a way as to create an even air current without turbulence. The air flow descending from top to bottom forms a front of sterile air that drags away any contaminating particles present and prevents them from rising again from the bottom of the chamber.
Inside the cleanroom there is provided the entrance for the operators assigned to performing a plurality of interventions on the packaging machine, such as, for example, adjustments, assembly and dismantling of parts and operating units, interventions that in all cases must not connect the sterile processing environment with non-sterile zones of the machine such as spaces containing mechanisms and movement mechanism.
The objective is to perform operations and interventions on the machine without compromising the sterility of the sterile environment and without contaminating previously sterilised parts and components mounted or to be mounted on the machine, in order to avoid procedures of restoring sterility that are laborious, long and very costly.
For this purpose, in order to avoid the contamination of the sterile environment, and above all of the parts with which they come into contact, the operators wear suitable protective overalls that cover all parts of their body.
In order to sterilize appropriately any object to be introduced into the cleanroom, there is provided an autoclave, provided with two hatches, which are respectively in communication with the external non-sterile environment and with the internal environment of the cleanroom, in such a way as to prevent a direct connection between said environments.
In this way the operator is able to introduce inside the cleanroom elements to be mounted onto the machine, typically standard components, operating units and devices, for example product batching or container capping devices, to be replaced at the end of production.
These parts are transferred manually by one or more operators from the autoclave to the machine on which they are mounted.
Recently however, the need has arisen to limit the intervention by operators to prevent them interacting directly with parts intended to come into contact with the product to be packaged, such as, for example, batching devices, components for introducing and supplying the product.
In fact, it has been observed that although operators are provided with protective gloves and overalls, they constitute a potential source of particle contamination.
The close proximity and the contact of said operators with sterile objects may cause the latter to be contaminated.
This possible and potential contamination may be considered to be unacceptable in certain packaging processes.
From this there arises the need to proceed with further sterilising processes after each operation and/or intervention on parts and components of the machine that are apt to come into contact with the product, with a consequent increase in the cost and time required to set up the operating system.
At the end of production it is generally necessary to dismantle the parts, the components and the operating units of the machine that have come into contact with the product or have a size that is not compatible with the next production batch. These elements have to be transferred outside the clean room to be cleaned, washed and then sterilised, to make them suitable for subsequent use.
The transfer outside the cleanroom occurs through a communicating chamber provided, similarly to the autoclave, with a first door giving access to the cleanroom and with a second door giving access to the non-sterile external environment. In this way the operators in the cleanroom transfer the elements dismantled from the machine to the chamber from which, after the first door has been closed hermetically, other operators remove them to subject them to washing and sterilising operations.
These manual procedures nevertheless have the drawback of forcing the operators to touch parts and components of the machine on which the packaged product is present in more or less great quantities. Also in the case of pharmaceutical products that are not particularly hazardous and harmful—such as cytotoxic products for which special procedures and containing systems are provided—this direct, prolonged and repeated contact with pharmaceuticals should be avoided as it exposes the operators to the possible absorption of unspecified quantities of product that may harm the health or cause health complaints of varying gravity. This is particularly true in the case of products in the form of fine powders, which can be easily diffused in the air and thus be inhaled and/or absorbed by the operators.
In order to overcome this problem it is currently necessary to limit the operating time of each operator, i.e. the time during which the latter is in contact with parts touched by the product. This is achieved through a frequent turnover of operators, which requires an appropriate number of operators to be made available and prepared for operations inside the cleanroom, with a consequent increase in system running costs.
Alternatively, it is necessary to provide the operators with particular equipment, such as completely airtight overalls and masks that are able to insulate the operators completely from the surrounding environment. In addition to being very costly, this equipment places significant limitations on movements and performable manual operations.